TetraSens Pediatric SEN 2009

GUDID 07350012440114

TetraSens Pediatric electrode

Senzime AB (Publ.)

Block-monitoring peripheral nerve electrical stimulation system

• Primary Device ID: 07350012440114
• NIH Device Record Key: 50f3b8b8-7069-4d2e-b7c9-57ef7bf0e194
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TetraSens Pediatric
• Version Model Number: SEN 2009 TetraSens Pediatric
• Catalog Number: SEN 2009
• Company DUNS: 559976316
• Company Name: Senzime AB (Publ.)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 2399204288
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com
• Phone: 800-213-1324
• Email: info.us@senzime.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350012440114 [Package]; Contains: 07350012440121; Package: Box [15 Units]; In Commercial Distribution
GS1	07350012440121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220530

FDA Product Code

• KOI: Stimulator, Nerve, Peripheral, Electric

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-15
• Device Publish Date: 2022-09-07

On-Brand Devices [TetraSens Pediatric]

• 07350012440114: TetraSens Pediatric electrode
• 07350012440190: TetraSens Pediatric EZConnect